Search results for "brazil"
Article
Finding Opportunities in Brazil
The facts about Brazil and its potential have not changed, as well as the natural resources available, interest in consumption of goods and medicines, growth potential of lower and middle classes, pop…
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Brazil Emerges as Global Biopharm Collaborator
The pharmaceutical market in Brazil has been growing steadily and strongly in the past five years. The country is eying production and innovation, relying on the key support of the government. Accordi…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
Brazil, Mexico, Venezuela, Columbia, and India now have at least draft, if not established, regulations for biosimilar approval in place. Russia is also developing an approval pathway, as are countrie…
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EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
…tect against new virus mutations that have been identified in the United Kingdom, South Africa, and Brazil. On Feb. 10, 2021, the agency announced that it is developing guidance to assist manufacture…
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The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
The situation in other countries varies, with countries like India, Brazil and China being less patent-owner-friendly and Europe being relatively more so; the issues in many countries involve compulso…
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Understanding Validation and Technical Transfer, Part I
The International Council for Harmonization (ICH), an organization composed of regulatory authorities from the US, Europe, Japan, Canada, Switzerland, Brazil, China, and the Republic of Korea, and rep…
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Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Also, if producing at commercial scale, which regulatory standard is needed? Is the product approved by FDA, the European Medicines Agency (EMA), the China FDA, Brazil’s National Health Surveillance A…
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Vaccine Development Faces Urgency and Challenges
Sanofi hopes to build on its success in producing a vaccine against dengue fever, which was approved in December 2015 in Mexico, Brazil, and the Philippines (2). GSK, Pfizer, Merck, Johnson & Johnson,…